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CBT for Insomnia in Breast Cancer Survivors (COIN Trial)
N/A
Recruiting
Led By Janelle Wilder Coughlin, PHD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Reports sleep problems present for ≥ 3 months
Diagnosed within 10 years with histologically-confirmed DCIS or stage I-III invasive carcinoma of the breast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (randomization); 8 weeks post-sleep intervention (prior to bwl); and at 3, 6, and 12 months post-bwl.
Awards & highlights
COIN Trial Summary
This trial will compare two treatments for overweight/obese women with early stage breast cancer and insomnia: one with an insomnia intervention before weight loss, and one with sleep education before weight loss. Outcomes will be measured at various time points.
Who is the study for?
This trial is for overweight or obese female breast cancer survivors, aged 18+, who have insomnia. They must be willing to lose weight and have completed cancer treatments at least 3 months prior. Exclusions include other sleep disorders (except mild apnea), drug abuse, current smokers, or those with unstable psychiatric conditions.Check my eligibility
What is being tested?
The study tests if Cognitive-Behavioral Therapy for Insomnia (CBT-I) enhances the effectiveness of a subsequent behavioral weight loss program compared to just receiving sleep education followed by the same weight loss program in women who've had early stage breast cancer.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from discussing personal issues during CBT-I sessions and typical challenges associated with lifestyle changes such as dieting and increased physical activity.
COIN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had trouble sleeping for 3 months or more.
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I was diagnosed with early-stage breast cancer or DCIS within the last 10 years.
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I have been diagnosed with insomnia according to DSM-5 standards.
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I am 18 years old or older.
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My BMI is 25 or higher and I weigh 400 lbs or less.
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I am female.
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My breast cancer is confirmed and not beyond stage III.
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I can take care of myself and am up and about more than half of my waking hours.
COIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (randomization); 8 weeks post-sleep intervention (prior to bwl); and at 3, 6, and 12 months post-bwl.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (randomization); 8 weeks post-sleep intervention (prior to bwl); and at 3, 6, and 12 months post-bwl.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Weight (pounds)
Secondary outcome measures
Body composition measured through DEXA scan
Diet quality as assessed by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool
Physical activity assessed by wearing and accelerometer to track movement.
COIN Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cognitive-Behavioral Therapy for Insomnia (CBT-I)Experimental Treatment1 Intervention
The proposed intervention consists of 6 remotely-delivered sessions; Weeks 1, 2, 4, 6, 7, and 8, with weeks 3 and 5 being "rest weeks". Session 1 will be 60-90 mins, Session 2 will be ~60 mins, and remaining visits are ~45 mins. The investigators propose a methodological innovation for CBT-I, which involves conducting 15-minute sessions every other month during the BWL intervention. Prior to these maintenance sessions, participants in the CBT-I+BWL group will complete electronic sleep diaries for one week and interventionists will use this information in sessions to sustain and enhance long-term outcomes by using MI to reinforce application of CBT-I session content.
Group II: Sleep Education Control (EDU)Placebo Group1 Intervention
The EDU intervention will parallel the CBT-I intervention in number, format and length of all sessions, including maintenance sessions. It provides basic information about sleep and cancer, widely available to the public. EDU content does not include any individualized behavioral instructions, sleep diary monitoring during the intervention, or behavior change counseling. Content is presented didactically only.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,655 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,110 Patients Enrolled for Breast Cancer
Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,822,914 Total Patients Enrolled
27 Trials studying Breast Cancer
23,258 Patients Enrolled for Breast Cancer
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,492,249 Total Patients Enrolled
49 Trials studying Breast Cancer
110,535 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with early-stage breast cancer or DCIS within the last 10 years.I am not planning to join any sleep or weight loss programs and my sleep test shows moderate to severe issues.You have trouble falling asleep or staying asleep for more than 30 minutes on most nights.I do not have any serious health or mental conditions that could interfere with treatment.You have a score of 9 or more on a test that measures how bad your insomnia is.I have been diagnosed with insomnia according to DSM-5 standards.I have had trouble sleeping for 3 months or more.I have a sleep disorder other than insomnia, but if it's sleep apnea, it's under control with PAP therapy.I am 18 years old or older.I am not taking sleep or weight affecting meds, excluding sedatives.You are okay with losing 10% of your body weight.My BMI is 25 or higher and I weigh 400 lbs or less.I am female.You have recently used recreational drugs or have a problem with alcohol or substance abuse.You smoke or use nicotine every day.My breast cancer is confirmed and not beyond stage III.I finished any planned surgeries more than 4 weeks ago.I finished my surgery, radiation, and any initial cancer treatments over 3 months ago.I can take care of myself and am up and about more than half of my waking hours.You have reported thinking about hurting yourself or have very strong feelings of sadness, as determined by a specific test.You have had a history of serious mental health problems that were not stable.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
- Group 2: Sleep Education Control (EDU)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research project recruiting participants at this time?
"As evinced by clinicaltrials.gov, this trial is no longer open for recruitment, having been initially posted on November 1st 2023 and last edited on March 21st 2023. However, there are currently 3175 other medical studies actively seeking participants."
Answered by AI
Who else is applying?
What site did they apply to?
Johns Hopkins Kimmel Cancer Center at Greenspring Station
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I have insomnia that is so severe. I’m only sleeping about two hours per 24. It’s ruining my life. I can’t function without sleep. Nothing has helped. I am seeking help desperately.
PatientReceived 2+ prior treatments
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